BioVaxys Technology Corp says the US Food and Drug Administration has provided the necessary guidance for the company to prepare an Investigational New Drug (IND) application for clinical trials of CoviDTH as a diagnostic for evaluating T-cell immune response to SARS-CoV-2.
The FDA, in its official written response to BioVaxys' request for a pre-IND Type B review of CoviDTH, found the chemistry, manufacturing and controls, and other elements of the clinical development program proposed by BioVaxys to be acceptable and provided guidance and feedback supportive of the company's clinical development plans.
In addition, the company said the FDA indicated that animal toxicity studies for CoviDTH were not required and that it could start its clinical development program with a combined Phase I/II study.
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Based on FDA feedback, BioVaxys said it will begin the preparation of an IND application to support a Phase I/II safety, dosing, and efficacy study.
BioVaxys submitted a pre-IND meeting request and briefing package with the FDA's Center for Biologics Evaluation and Research (CBER) for CoviDTH earlier this year.
The Pre-IND review is a critical step in the US regulatory approval process, as it affords an opportunity for study sponsor companies to seek clarification from the FDA on clinical trials design, clinical materials manufacturing, quality controls, etc.
"With the guidance we received from this FDA review, BioVaxys is now able to begin preparing its IND," said BioVaxys President and Chief Operating Officer Ken Kovan in a statement. "Although the FDA has indicated that our planned animal tox study is discretionary, we will likely continue with the animal tox study of CoviDTH as it does not interfere with the development time frame and may in fact provide useful data."
CEO James Passin added: "We are pleased to advance CoviDTH towards clinical trials, as we believe that mass screening for T cell immunity to Covid-19 will represent a critical tool for public health authorities to address the continued pandemic, as Covid variants continue to circulate and major governments in the southern hemisphere enact new lockdown policies."
The company noted it is not making any express or implied claims that its product has the ability to eliminate, cure, or contain Covid-19 (SARS-CoV-2) at this time.
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